U.S. patent number 6,913,609 [Application Number 09/967,684] was granted by the patent office on 2005-07-05 for access port system for anastomosis.
This patent grant is currently assigned to Cardica, Inc.. Invention is credited to Bernard A. Hausen, Jaime S. Vargas, Stephen A. Yencho.
United States Patent |
6,913,609 |
Yencho , et al. |
July 5, 2005 |
Access port system for anastomosis
Abstract
A method of performing anastomosis includes securing an access
port system to an exterior surface of the target vessel to assist
in axial alignment, depth registration, and/or sealing when
inserting instruments such as punching instruments and anastomosis
instruments into the target vessel.
Inventors: |
Yencho; Stephen A. (Menlo Park,
CA), Hausen; Bernard A. (Menlo Park, CA), Vargas; Jaime
S. (Menlo Park, CA) |
Assignee: |
Cardica, Inc. (Redwood City,
CA)
|
Family
ID: |
25513160 |
Appl.
No.: |
09/967,684 |
Filed: |
September 28, 2001 |
Current U.S.
Class: |
606/153;
604/167.01 |
Current CPC
Class: |
A61B
17/11 (20130101); A61B 17/3417 (20130101); A61B
2017/1107 (20130101); A61B 2017/1135 (20130101); A61B
2017/306 (20130101); A61B 2017/3419 (20130101); A61B
2017/3445 (20130101); A61B 2017/3466 (20130101); A61B
2017/3488 (20130101); A61F 2/064 (20130101) |
Current International
Class: |
A61B
17/11 (20060101); A61B 17/03 (20060101); A61B
17/30 (20060101); A61B 17/34 (20060101); A61F
2/06 (20060101); A61B 017/08 () |
Field of
Search: |
;606/151,153,154,155,159,184,185
;604/167.01,167.02,288.01,164.04,174 ;128/898 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Woo; Julian W.
Assistant Examiner: Nguyen; Victor
Attorney, Agent or Firm: Schar; Brian A. Lynch; Cindy A.
Claims
What is claimed is:
1. A method of performing a vascular anastomosis procedure, the
method comprising: substantially sealing an access port system to a
target vessel; inserting a tissue cutter through the access port
system, while providing a seal between the access port system and
the tissue cutter; forming an opening in a side wall of the target
vessel with the tissue cutter; removing the tissue cutter from the
access port system; inserting an anastomosis instrument through the
access port system, while providing a seal between the access port
system and the anastomosis instrument; and performing a vascular
anastomosis between a graft vessel and the target vessel with the
anastomosis instrument.
2. The method of claim 1, wherein the access port system ensures a
desired axial alignment of the tissue cutter and the anastomosis
instrument.
3. The method of claim 1, wherein the tissue cutter and anastomosis
instrument are inserted to a predetermined depth by registration
provided by the access port system.
4. The method of claim 1, further comprising the step of
maintaining hemostasis between the steps of removing the tissue
cutter and inserting the anastomosis instrument.
5. The method of claim 4, wherein the step of maintaining
hemostasis is performed by a seal within the access port
system.
6. The method of claim 1, wherein the step of sealing the access
port system to an exterior of the target vessel is performed by
manual pressure.
7. The method of claim 1, wherein the step of sealing the access
port system to an exterior of the target vessel is performed by
applying a suction to an exterior wall of the target vessel with
the access port system.
8. The method of claim 1, wherein the vascular anastomosis
procedure is a closed chest procedure.
9. The method of claim 1, wherein the access port system is sealed
to an exterior of the target vessel.
10. The method of claim 1, wherein the access port system is sealed
to an interior of the opening in the target vessel.
11. A method of performing a vascular anastomosis procedure, the
method comprising: substantially sealing an access port system to a
target vessel; inserting a tissue cutter through the access port
system; forming an opening in a side wall of the target vessel with
the tissue cutter; removing the tissue cutter from the access port
system; providing a seal in the access port system to substantially
prevent blood loss from the opening in the target vessel; inserting
an anastomosis instrument through the access port system; and
performing a vascular anastomosis between a graft vessel and the
target vessel with the anastomosis instrument.
12. The method of claim 11, wherein the access port system ensures
a desired axial alignment of the tissue cutter and the anastomosis
instrument.
13. The method of claim 11, wherein the tissue cutter and
anastomosis instrument are inserted to a predetermined depth by
registration provided by the access port system.
14. The method of claim 11, wherein the step of sealing the access
port system to an exterior of the target vessel is performed by
manual pressure.
15. The method of claim 11, wherein the step of sealing the access
port system to an exterior of the target vessel is performed by
applying a suction to an exterior wall of the target vessel with
the access port system.
16. A method of performing a vascular anastomosis procedure, the
method comprising: positioning an access port system at a target
vessel; inserting a tissue cutter through the access port system,
while providing registration of a position of the tissue cutter
with the access port system; forming an opening in a side wall of
the target vessel with the tissue cutter; removing the tissue
cutter from the access port system; inserting an anastomosis
instrument through the access port system, while providing
registration of a position of the anastomosis instrument with the
access port system; and preforming vascular anastomosis between a
graft vessel and the target vessel with the anastomosis
instrument.
17. The method of claim 16, wherein the access port system provides
depth registration for the tissue cutter and the anastomosis
instrument.
18. The method of claim 16, wherein the access port system provides
axial alignment for the tissue cutter and the anastomosis
instrument.
19. The method of claim 16, wherein the access port system provides
hemostasis for the opening formed in the target vessel.
Description
FIELD OF THE INVENTION
The invention relates to an anastomosis system, and more
particularly, the invention relates to an access port system for a
vascular anastomosis procedure.
DESCRIPTION OF THE RELATED ART
Vascular anastomosis is a procedure by which two blood vessels
within a patient are surgically joined together. Vascular
anastomosis is performed during treatment of a variety of
conditions including coronary artery disease, diseases of the great
and peripheral vessels, organ transplantation, and trauma. In
coronary artery disease (CAD) an occlusion or stenosis in a
coronary artery interferes with blood flow to the heart muscle.
Treatment of CAD involves the grafting of a vessel in the form of a
prosthesis or harvested artery or vein to reroute blood flow around
the occlusion and restore adequate blood flow to the heart muscle.
This treatment is known as coronary artery bypass grafting
(CABG).
In the conventional CABG, a large incision is made in the chest and
the sternum is sawed in half to allow access to the heart. In
addition, a heart lung machine is used to circulate the patient's
blood so that the heart can be stopped and the anastomosis can be
performed. In order to minimize the trauma to the patient induced
by conventional CABG, less invasive techniques have been developed
in which the surgery is performed through small incisions in the
patients chest with the aid of visualizing scopes. Less invasive
CABG can be performed on a beating or stopped heart and thus may
avoid the need for cardiopulmonary bypass.
In both conventional and less invasive CABG procedures, the surgeon
has to suture one end of the graft vessel to the coronary artery
and the other end of the graft vessel to a blood supplying vein or
artery, such as the aorta. The suturing process is a time consuming
and difficult procedure requiring a high level of surgical skill.
Automated anastomosis systems are being developed to replace the
suturing process in which one or more automated connecting members
connect a graft vessel and a target vessel without suturing.
However, when these automated anastomosis systems are deployed it
is often difficult to properly align the graft vessel to the hole
which is formed in the target vessel. In addition, there is often a
problem of blood loss through the hole in the target vessel after
the hole is formed and before the anastomosis procedure is
completed. Blood loss may be prevented by clamping off the target
vessel. However, clamping is undesirable because it may cause
plaque to be dislodged and may cause neurological
complications.
Accordingly, it would be desirable to provide an access port system
for a sutureless vascular anastomosis device which assists in axial
alignment, depth registration, and sealing to prevent blood loss
when inserting tools into a target vessel.
SUMMARY OF THE INVENTION
The present invention relates to an access port system for a
vascular anastomosis procedure.
In accordance with one aspect of the present invention, a system
for performing a vascular anastomosis procedure between a graft
vessel and a target vessel includes a sealing element configured to
substantially seal to a target vessel, a port connected to the
sealing element and configured to allow passage of one or more
instruments through the port and into the target vessel when the
sealing element is substantially sealed to the exterior surface of
the target vessel, a tissue cutter configured to be inserted
through the port to form an opening in a side wall of the target
vessel, an instrument configured to be inserted through the port to
connect a graft vessel to the target vessel, and a seal configured
to provide a seal between the port and the tissue cutter, and to
provide a seal between the port and the instrument.
In accordance with an additional aspect of the present invention, a
method of performing a vascular anastomosis procedure includes:
substantially sealing an access port system to a target vessel;
inserting a tissue cutter through the access port system, while
providing a seal between the access port system and the tissue
cutter; forming an opening in a side wall of the target vessel with
the tissue cutter; removing the tissue cutter from the access port
system; inserting an anastomosis instrument through the access port
system, while providing a seal between the access port system and
the anastomosis instrument; and performing a vascular anastomosis
between a graft vessel and the target vessel with the anastomosis
instrument.
In accordance with a further aspect of the present invention, a
system for performing a vascular anastomosis procedure between a
graft vessel and a target vessel includes an access port configured
to provide hemostasis for a side hole in a target vessel for the
placement of an anastomosis device without the need to clamp the
target vessel.
In accordance with another aspect of the present invention, a
method of performing a vascular anastomosis procedure includes the
steps of: substantially sealing to a target vessel; inserting a
tissue cutter through the access port system; forming an opening in
a side wall of the target vessel with the tissue cutter; removing
the tissue cutter from the access port system; providing a seal in
the access port system to substantially prevent blood loss from the
opening in the target vessel; inserting an anastomosis instrument
through the access port system; and performing a vascular
anastomosis between a graft vessel and the target vessel with the
anastomosis instrument.
In accordance with an additional aspect of the present invention, a
method of performing a vascular anastomosis procedure includes the
steps of: positioning an access port system at a target vessel;
inserting a tissue cutter through the access port system, while
providing registration of a position of the tissue cutter with the
access port system; forming an opening in a side wall of the target
vessel with the tissue cutter; removing the tissue cutter from the
access port system; inserting an anastomosis instrument through the
access port system, while providing registration of a position of
the anastomosis instrument with the access port system; and
performing vascular anastomosis between a graft vessel and the
target vessel with the anastomosis instrument.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
The invention will now be described in greater detail with
reference to the preferred embodiments illustrated in the
accompanying drawings, in which like elements bear like reference
numerals, and wherein:
FIG. 1 is a perspective view of an access port system positioned on
an aorta for performing a vascular anastomosis procedure;
FIG. 2 is a perspective view of an alternative embodiment of an
access port system positioned on a blood vessel with a tissue
cutter arranged to be inserted through the access port;
FIG. 3 is an enlarged perspective view of a further alternative
embodiment of an access port system with a tissue cutter and an
instrument for performing anastomosis;
FIG. 4 is a cross sectional perspective view of the access port
system of FIG. 3;
FIG. 5 is a bottom view of the access port system of FIG. 3;
FIG. 6 is a perspective view of the access port system of FIG. 3
once the anastomosis has been performed and the access port system
is being removed;
FIG. 7 is a perspective view of another alternative embodiment of
an access port system; and
FIG. 8 is a cross sectional perspective view of an alternative
embodiment of the access port system of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
An access port system 10, as shown in FIG. 1, provides a passageway
through which instruments are inserted into a target vessel during
performance of an anastomosis procedure. The access port system 10
is apposed to an exterior surface of the target vessel and assists
in axial alignment, depth registration, and sealing when inserting
instruments into the target vessel. The access port system 10
provides the capability of placing punching instruments,
anastomosis instruments, and other instruments in their correct
positions relative to a target vessel and providing hemostasis
while inserting instruments into and removing instruments from the
target vessel. The access port system 10 also provides hemostasis
for the placement of an anastomosis device without clamping the
target vessel.
The access port system 10 includes a sealing element or sealing
plate 12 which is configured to conform to and substantially seal
to an exterior wall of a target blood vessel 100, such as the
aorta. A port 14 is connected to the sealing plate 12 and is
configured to allow passage of instruments through the port and
into the target vessel 100. The port 14 is a tubular member which
provides axial and longitudinal alignment or registration of
instruments inserted into the target vessel 100. A proximal end of
the port 14 is provided with a seal 16 in the form of a flapper
valve, an elastomeric valve, or other valve. The seal 16 provides
hemostasis while moving instruments into and out of the port 14. In
particular, the seal 16 prevents blood loss from an opening formed
in the target vessel by completely sealing the lumen of the port 14
when no instrument is in use and by sealing around a instrument
when the instrument is inserted into the port.
The access port system 10 of FIG. 1 is used in an anastomosis
procedure by first locating a position on a target vessel 100 for
connection of the graft vessel. The access port system 10 is then
held at the desired position and the sealing plate 12 is secured in
place against the exterior wall of the target vessel 100. The
sealing plate 12 may be secured in place by manually pressing the
sealing plate against the target vessel, by suction as will be
described below, by a temporary adhesive, or by other known
methods.
Once the access port system 10 is positioned on the target vessel,
a tissue cutter is inserted through the lumen of the port 14 and
forms an opening in the target vessel. The term "tissue cutter," as
used herein, is intended to mean any instrument which forms an
opening in a target vessel, including tissue punches which cut a
plug of tissue and tissue cutters which form an incision. The
tissue cutter is then removed and an instrument for performing
anastomosis is inserted through the port 14. The anastomosis
procedure is then performed.
The instrument for performing anastomosis may be any of the known
automated anastomosis systems such as those that use staples,
sutures, one piece devices, or multi-piece devices to connect an
end of a graft vessel to an opening in a side wall of a target
vessel. Examples of anastomosis instruments are described in U.S.
Pat. Nos. 6,179,849 and 6,206,913 and in WO 00/69343 and WO
01/08601.
Axial alignment of the instruments with the opening in the target
vessel is provided by the port 14. In addition, depth registration
of the instruments may be provided by features, such as protrusions
within the port 14 or a proximal end of the port. An actuator
handle 18 may also be provided to register the tissue cutter and/or
other instruments within the port 14.
Once the anastomosis procedure has been completed, the instrument
and the access port system 10 are removed from the target vessel
leaving the graft vessel connected to the target vessel. The access
port system 10 and instrument may be removed together or
separately.
FIG. 2 illustrates an alternative embodiment of an access port
system 20 having a sealing plate 22 and a port 24 which is shorter
than the one shown in FIG. 1. FIG. 2 also shows one exemplary
embodiment of a tissue cutter 30 for use with the access port
system. The tissue cutter 30 has a conical shaped anvil 32 which
penetrates the target vessel wall and an annular cutting edge 34
which moves with respect to the anvil by actuation of the punch
handle 36 to remove a plug of tissue. As in the embodiment of FIG.
1, the access port system 20 includes an internal seal (not shown)
within the port 24 which prevents blood leakage when no instrument
is present in the port and provides a seal around the instruments
when present.
FIG. 3 illustrates an alternative embodiment of an access port
system 40 which includes a sealing plate 42 and a centrally located
port 44 having a sealing valve 46. Arranged on opposite sides of
the port 44 are two vacuum risers 48 which deliver a suction to
seal the sealing plate 42 to the exterior wall of the target vessel
100. The suction risers 48 each have a distal end in fluid
communication with a bottom side of the sealing plate 42 and a
proximal end configured to receive a suction tube which is
connected to a suction source with a variable suction.
As shown in FIGS. 4 and 5, the sealing plate 42 includes a
plurality of sealing ribs 52 on a bottom side or tissue contacting
side of the plate. The sealing ribs 52 create channels which assist
in suction sealing of the sealing plate 42 to the wall of the blood
vessel. Although the ribs 52 illustrated form parallel channels,
channels of other shapes may also be created. In addition, although
two suction risers 48 have been shown, any number and arrangement
of suction risers may be used to secure the sealing plate to the
wall of the target vessel 100.
FIG. 3 also shows a schematic illustration of a tissue cutter 50
and an anastomosis instrument 60 with an attached anastomosis
device 62 and a graft vessel 64. The tissue cutter 50 and the
anastomosis instrument 60 are both configured to be inserted
through the port 44 and into the target vessel 100. The tissue
cutter 50 and anastomosis instrument 60 are merely schematic
representations of the type of instruments which may be used. Other
known surgical instruments may also be used with the access port
system of the present invention.
The seal 46 illustrated in FIG. 3 is shown in an open position in
which the instruments would be received. In a closed position, as
shown in FIG. 4, the seal 46 will completely close a lumen of the
port 44 preventing blood loss from the anastomosis site. The seal
46 may be an elastomeric seal, flapper valve, or other known seal.
The seal 46 is preferably formed of a biocompatible material such
as silicone, latex, plastic, nylon, or other material.
FIG. 6 illustrates the removal of the access port system 40 after
the end of a graft vessel 64 has been connected to the target
vessel 100. In FIG. 6, the access port system 40 and the
anastomosis instrument 60 are being removed simultaneously from the
anastomosis site as the graft vessel 64 slides out of the
anastomosis instrument.
FIG. 7 illustrates an alternative embodiment of an access port
system 70 in which a hemostasis seal 76 is centrally located within
the port 74. It should be understood that the location and
configuration of the seal 76 may be varied without departing from
the invention.
FIG. 8 illustrates an alternative embodiment of an access port
system in which the port 84 includes a first seal 86 and a second
seal 88. The first seal 86 is in the form of a resilient sealing
ring or gasket and provides a seal between the port 84 and the
instruments inserted into the port. The second seal 88 is a disk
shaped flapper valve which provides hemostasis when instruments are
not received in the port 84. The flapper valve 88 seats against the
resilient ring 86 in a closed position and is mounted on a
resilient hinge 90 which allows the flapper valve to be pushed out
of the way by an inserted instrument. The embodiment of FIG. 8 also
includes an inwardly extending portion 92 of the port 84 which
allows the access port system to provide sealing within an opening
formed in the target vessel.
Although the illustrated embodiments of the access port system
according to the present invention include a port which is
substantially perpendicular to the wall of the blood vessel, it may
be desirable to provide a port arranged at a predefined angle with
respect to the blood vessel. For example, when forming an
anastomosis between a graft vessel and a coronary artery it is
desirable to position the graft at an angle so that blood flow from
the graft passes into the coronary with minimal turbulence and
associate thrombosis.
The access port systems according to the present invention may be
used either in open chest or closed chest surgery and on a beating
or stopped heart. The access port systems may be used for proximal
or distal anastomosis, i.e. connection of a graft vessel to the
aorta or coronary artery. The graft vessel may be a natural or
synthetic graft, a mammary artery, or other vessel used for
performing an anastomosis procedure. Although the invention is
particulary designed for use in performing vascular anastomosis it
may also be used for other non-vascular anastomosis.
While the invention has been described in detail with reference to
the preferred embodiments thereof, it will be apparent to one
skilled in the art that various changes and modifications can be
made and equivalents employed, without departing from the present
invention.
* * * * *